{"entity":{"id":"genius-digital-diagnostics","kind":"drug","name":"Genius Digital Diagnostics System with Genius Cervical AI (Hologic)","aka":["Genius Cervical AI"],"tldr":"The first FDA-authorised system (January 2024) for reading Pap test slides as digital images with the help of artificial intelligence.","summary":"The FDA granted De Novo DEN210035 to Hologic for the Genius Digital Diagnostics System with the Genius Cervical AI algorithm on 31 January 2024, creating the classification \"digital cervical cytology slide imaging system with artificial intelligence algorithm\" (product code QYV, 21 CFR 864.3900, class II). The FDA defines the type as a prescription in vitro diagnostic device \"consisting of an automated digital slide creation, viewing, and management system intended to aid in the review of digital images of slides prepared from Pap\" specimens.","status":"approved","asOf":"2026-11-04","links":[{"label":"FDA De Novo DEN210035","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN210035"}],"tags":["test","screening-test"],"related":["automated-pap-screening-readers","thinprep","fda-device-databases"],"cancers":["cervical"],"sections":["early-detection","diagnostics"],"technologies":["hpv-testing","radiology-ai-screening"],"targets":[],"drugs":[],"companies":["hologic"],"institutions":[],"pathways":[],"terms":["screening"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Genius Digital Diagnostics","modality":"Digital Pap test imaging with an artificial intelligence algorithm","mechanism":"Pap slides are scanned into digital images and an artificial intelligence algorithm selects the cells and regions a cytologist should review on screen.","approvals":[{"region":"US","year":2024,"indication":"Digital cervical cytology review aided by an AI algorithm (De Novo DEN210035)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2024-01-31","type":"approval","region":"US","note":"De Novo granted (DEN210035)","source":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN210035"}]},"route":"/drugs/genius-digital-diagnostics/","neighbours":{"drug":[{"id":"automated-pap-screening-readers","kind":"drug","name":"Automated Pap slide readers: BD FocalPoint and the ThinPrep Imaging System","route":"/drugs/automated-pap-screening-readers/"},{"id":"thinprep","kind":"drug","name":"ThinPrep Pap Test and ThinPrep processors (Hologic)","route":"/drugs/thinprep/"}],"collection":[{"id":"fda-device-databases","kind":"collection","name":"FDA medical device databases (PMA, 510(k), De Novo)","route":"/collections/fda-device-databases/"}],"cancer":[{"id":"cervical","kind":"cancer","name":"Cervical cancer","route":"/cancers/cervical/"}],"section":[{"id":"diagnostics","kind":"section","name":"Diagnostics & Biomarkers","route":"/fronts/diagnostics/"},{"id":"early-detection","kind":"section","name":"Early Detection & Screening","route":"/fronts/early-detection/"}],"technology":[{"id":"radiology-ai-screening","kind":"technology","name":"AI in radiology","route":"/technologies/radiology-ai-screening/"},{"id":"hpv-testing","kind":"technology","name":"HPV DNA testing and self-sampling","route":"/technologies/hpv-testing/"}],"company":[{"id":"hologic","kind":"company","name":"Hologic","route":"/companies/hologic/"}],"term":[{"id":"screening","kind":"term","name":"Screening","route":"/terms/screening/"}]}}